IDDI Comments on FDA Draft Guidance on Expansion Cohorts
The need to consider randomization whenever feasible in expansion cohorts
The purpose of IDDI comments on FDA Draft guidance is to emphasize the need to consider randomization whenever feasible in expansion cohorts, even though randomization has rarely been used until now in this setting. Our view is that the use of a randomized control group should be considered when designing any clinical trial, including an expansion cohort, in order to produce an unbiased assessment of a drugs efficacy.
With a scientifically-driven culture, IDDI has always been at the forefront of methodological research (over 800 scientific publications). We believe that the most efficient and cost-effective way to design and conduct clinical trials is to make the best possible use of advanced and innovative statistical methodology. We have a particular interest in improving and proposing statistical methods that can make your clinical development more efficient and reliable.
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